Arcutis Presents New Phase 2 Results in Infants with Atopic Dermatitis in Late-Breaking Session Today at the 2026 American Academy of Dermatology Annual Meeting

• Investigational ZORYVE® (roflumilast) cream 0.05% was well tolerated with safety findings consistent with prior pediatric experience in the INTEGUMENT program
• ZORYVE cream improved signs and symptoms of mild to moderate atopic dermatitis in infants aged 3 months to less than 24 months over four weeks
• Caregivers reported rapid improvement in itch in as little as 10 minutes in nearly half of infants
• Results from additional studies across the ZORYVE portfolio being presented in three poster presentations

WESTLAKE VILLAGE, Calif. and DENVER, March 28, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new data from the INTEGUMENT-INFANT Phase 2 trial demonstrating that ZORYVE® (roflumilast) cream 0.05% reduced signs and symptoms of atopic dermatitis, the most common form of eczema, in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. These results build upon the topline results announced last month and further support the potential of investigational ZORYVE cream as a treatment option for this youngest and very vulnerable population. The results were presented today during a late-breaking podium presentation at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, CO.

“Infantile atopic dermatitis presents daily challenges for affected patients and their families, and clinicians have limited topical options to treat it,” said Lawrence F. Eichenfield, MD, of Rady Children’s Hospital San Diego and the University of California San Diego School of Medicine, and presenting author of the INTEGUMENT‑INFANT data. “The rashes and itch of eczema result in disrupted sleep and significant distress for both infants and their families. In this Phase 2 study, once‑daily ZORYVE cream 0.05% provided meaningful improvements in severity of the signs and symptoms of disease over four weeks, with caregivers reporting rapid relief of itch in as little as 10 minutes. The study results show that ZORYVE cream was effective with a safe and well-tolerated profile in infants down to 3 months of age.”

The INTEGUMENT-INFANT open-label trial evaluated the safety and tolerability of once-daily ZORYVE cream 0.05% in infants (n=101) aged 3 months to less than 24 months with mild to moderate atopic dermatitis over four weeks. The Phase 2 study results reinforce the consistency of the safety and tolerability profile of ZORYVE cream 0.05% already seen in the four-week pivotal INTEGUMENT-PED clinical trial in children aged 2 to 5 years. The most frequently reported adverse events (≥3%; n=101) included: diarrhea, nasopharyngitis, upper respiratory tract infection, and vomiting. Only one trial participant discontinued the study due to an adverse event, and there were no serious adverse events. In addition, based on investigator-rated local tolerability assessments, ≥97.9% of infants experienced no application site irritation throughout the four weeks.In new data released today, among participants who completed four weeks of treatment (n=96), 34.4% achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success (defined as a score of 0 (Clear) or 1 (Almost Clear) with a ≥2-grade improvement). In addition, 49% of infants achieved a vIGA-AD score of Clear or Almost Clear (0 or 1) at Week 4, and 24% already at Week 2. For those infants with at least mild scalp involvement at baseline (n=40), 67.5% achieved vIGA-scalp success (scalp Clear or Almost Clear (0 or 1) with ≥2-point improvement from baseline) at Week 4. As previously reported, 58.3% of infants achieved at least a 75% reduction in Eczema Area and Severity Index (EASI-75) at Week 4 (n=96), and 34% of infants at Week 2 (n=100).

In addition, caregivers reported improvement in itch. Itch improvement, as assessed by caregivers using the Worst Scratch Itch Numeric Rating Scale (WSI-NRS)—a measure validated in patients aged 6 months to 6 years—showed that 72.7% of infants achieved WSI-NRS success, defined as a ≥4-point improvement at the end of the study, at Week 4 (n=77) and 60.3% at Week 2 (n=73). Furthermore, 66.7% of infants achieved at least a 25% improvement from baseline in pruritus based on the Dynamic Pruritus Scale (DPS-25) at four hours (n=87), 58.6% at one hour (n=87), and 46.6% at 10 minutes (n=88).

“Atopic dermatitis often begins in the first months of life, underscoring the need for therapies that are both safe and effective and can be used anywhere on the body for these youngest of patients,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis. “Findings from the INTEGUMENT-INFANT study add important clinical evidence for investigational ZORYVE cream 0.05% in infants 3 to